[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100516163":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":10,"centralContacts":25,"locations":31,"responsibleParty":143,"collaborators":10,"id":145,"slug":10,"hasResults":146,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":150,"eligibilityCriteria":151,"healthyVolunteers":146,"sex":152,"minAge":153,"maxAge":10,"enrollmentInfo":154,"targetDuration":157,"studyType":158,"phases":10,"briefSummary":159,"conditions":160,"keywords":10,"overallStatus":34,"whyStopped":10,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":172},{"fullName":5,"class":6},"Niguarda Hospital","OTHER",[8,14,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Lower Surgical Risk",null,"Surgical risk stratification. All the following groups will be define according with STS and Euroscore II score and stratified based on antithrombotic strategy in all possible combinations (SAPT, DAPT, OAC, OAC+SAPT)",[13],"Other: Low vs Intermediate vs High surgical risk stratified according with SAPT\u002FDAPT\u002FOAC and OAC+SAPT",{"label":15,"type":10,"description":11,"interventionNames":16},"Intermediate Surgical Risk",[13],{"label":18,"type":10,"description":11,"interventionNames":19},"High Surgical Risk",[13],[21],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"Low vs Intermediate vs High surgical risk stratified according with SAPT\u002FDAPT\u002FOAC and OAC+SAPT","All patients undergoing TAVR will be stratified according with surgical risk level and all combination of antithrombotic therapy at discharge\n\nLow risk (SAPT vs DAPT and OAC vs OAC+SAPT) Intermediate risk (SAPT vs DAPT and OAC vs OAC+SAPT) High risk (SAPT vs DAPT and OAC vs OAC+SAPT)",[18,15,9],[26],{"name":27,"role":28,"phone":29,"phoneExt":10,"email":30},"Giuseppe Esposito, MD","CONTACT","+393278393131","giuseppe.esposito@yahoo.com",[32,44,54,64,78,88,96,104,109,117,125,133],{"facility":33,"status":34,"city":35,"state":10,"zip":10,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":10},"OLV Hospital","RECRUITING","Aalst","Belgium","BE",{"type":39,"coordinates":40},"Point",[41,42],4.0355,50.93604,{"lat":42,"lon":41},{"facility":45,"status":34,"city":46,"state":10,"zip":10,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":53,"contacts":10},"Complejo Asistencial Dr. Sótero del Río","Santiago","Chile","CL",{"type":39,"coordinates":50},[51,52],-70.64827,-33.45694,{"lat":52,"lon":51},{"facility":55,"status":34,"city":56,"state":10,"zip":57,"country":58,"countryCode":10,"cosmosGeoPoint":59,"geoPoint":63,"contacts":10},"Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske Vinohrady","Prague","10034","Czechia",{"type":39,"coordinates":60},[61,62],14.42076,50.08804,{"lat":62,"lon":61},{"facility":65,"status":34,"city":66,"state":67,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"ASST GOM Niguarda","Milan","Italia","20162","Italy","IT",{"type":39,"coordinates":72},[73,74],12.59836,42.78235,{"lat":74,"lon":73},[77],{"name":27,"role":28,"phone":29,"phoneExt":10,"email":30},{"facility":79,"status":34,"city":80,"state":81,"zip":82,"country":69,"countryCode":70,"cosmosGeoPoint":83,"geoPoint":87,"contacts":10},"Humanitas Research Hospital","Rozzano","Milano","20089",{"type":39,"coordinates":84},[85,86],9.1559,45.38193,{"lat":86,"lon":85},{"facility":89,"status":34,"city":90,"state":81,"zip":10,"country":69,"countryCode":70,"cosmosGeoPoint":91,"geoPoint":95,"contacts":10},"IRCCS Policlinico San Donato","San Donato Milanese",{"type":39,"coordinates":92},[93,94],9.26838,45.41047,{"lat":94,"lon":93},{"facility":97,"status":34,"city":98,"state":10,"zip":10,"country":69,"countryCode":70,"cosmosGeoPoint":99,"geoPoint":103,"contacts":10},"IRCCS Ospedale Policlinico San Martino","Genova",{"type":39,"coordinates":100},[101,102],11.87211,45.21604,{"lat":102,"lon":101},{"facility":105,"status":34,"city":66,"state":10,"zip":10,"country":69,"countryCode":70,"cosmosGeoPoint":106,"geoPoint":108,"contacts":10},"Ospedale Galeazzi Sant'Ambrogio",{"type":39,"coordinates":107},[73,74],{"lat":74,"lon":73},{"facility":110,"status":34,"city":111,"state":10,"zip":10,"country":69,"countryCode":70,"cosmosGeoPoint":112,"geoPoint":116,"contacts":10},"San Carlo Hospital","Potenza",{"type":39,"coordinates":113},[114,115],15.80794,40.64175,{"lat":115,"lon":114},{"facility":118,"status":34,"city":119,"state":10,"zip":10,"country":69,"countryCode":70,"cosmosGeoPoint":120,"geoPoint":124,"contacts":10},"Azienda Ospedaliera Sant'Andrea","Roma",{"type":39,"coordinates":121},[122,123],11.10642,44.99364,{"lat":123,"lon":122},{"facility":126,"status":34,"city":127,"state":10,"zip":10,"country":69,"countryCode":70,"cosmosGeoPoint":128,"geoPoint":132,"contacts":10},"A.O.U. Città della Salute e della Scienza di Torino","Torino",{"type":39,"coordinates":129},[130,131],11.99138,44.88856,{"lat":131,"lon":130},{"facility":134,"status":34,"city":135,"state":10,"zip":10,"country":136,"countryCode":137,"cosmosGeoPoint":138,"geoPoint":142,"contacts":10},"Puerto Real University Hospital, Puerto Real","Cadiz","Spain","ES",{"type":39,"coordinates":139},[140,141],-6.2891,36.52672,{"lat":141,"lon":140},{"type":144,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100516163",false,"NCT06000943","Ischemic And Bleeding Risk Assessment After TAVR","Ischemic And Bleeding Risk Assessment After TAVR (FOCUS ONE Registry)","FOCUS ONE","Inclusion criteria\n\n* All patients with severe aortic stenosis undergoing TAVR.\n* Availability of changes in antithrombotic therapy at 1 month, 90 days, and 1 year after TAVR.\n\nExclusion Criteria\n\n* Patients who died during the index procedure\n* Patients in triple antithrombotic therapy at discharge\n* Patients with a known prognosis less than 1 year at the time of TAVR","ALL","18 Years",{"count":155,"type":156},2500,"ESTIMATED","3 Years","OBSERVATIONAL","Transcatheter aortic valve replacement (TAVR) represents an effective treatment to improve symptoms and prognosis in patients with symptomatic severe aortic stenosis (AS) (1-2).\n\nGiving an established uniform approach towards anticoagulation and antithrombotic therapy after TAVR in the post POPULAR-TAVI era, recent data coming from the analysis of different trials, highlight the relevance of the patient's background on the occurrence of ischemic and bleeding events.\n\nDespite this a targeted antithrombotic strategy remains unexplored and all patients undergoing TAVR without other indication to DAPT or OAC, were currently treated according with the concept of \"less is more\" (only SAPT or only OAC) regardless the risk level (5-6).\n\nThe keys points of the project will be 1) the assessment of ischemic and bleeding risk after TAVR stratified according with antithrombotic therapy and surgical risk; 2) the evaluation of the impact of prostheses type and the complete blood count variables (hemoglobine and platelets) on the daily average ischemic and bleeding risk and 3) the evaluation of the dynamic therapeutic changes after TAVR during the follow up.",[161,162],"Aortic Valve Stenosis","Transcatheter Aortic Valve Replacement","2026-04-13",{"date":165,"type":166},"2026-04-16","ACTUAL",{"date":168,"type":166},"2023-08-01",{"date":170,"type":156},"2026-12-15",{"name":5,"class":6},12]